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CTRI Number  CTRI/2023/05/052348 [Registered on: 08/05/2023] Trial Registered Prospectively
Last Modified On: 05/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Prevalence of High-Risk Human Papilloma Virus in HIV Positive women 
Scientific Title of Study   Prevalence of High-Risk Human Papilloma Virus with Genotype Assessment in HIV Positive women: A Cross sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Riddhi Jadhav 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences Rishikesh 
Address  Level 6, Academic Block, Department of Obstetrics and Gynecology, AIIMS Rishikesh Virbhadra Marg, Shivaji Nagar, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9518911425  
Fax    
Email  riddhijadhav38@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini Rajaram 
Designation  Professor and Program coordinator MCh Gynaecologic Oncology 
Affiliation  AIIMS Rishikesh 
Address  Level 6, Academic Block, Department of Obstetrics and Gynecology, AIIMS Rishikesh Virbhadra Marg, Shivaji Nagar, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9810704434  
Fax    
Email  rajaram.shalini@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shalini Rajaram 
Designation  Professor and Program coordinator MCh Gynaecologic Oncology 
Affiliation  AIIMS Rishikesh 
Address  Level 6, Academic Block, Department of Obstetrics and Gynecology, AIIMS Rishikesh Virbhadra Marg, Shivaji Nagar, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9810704434  
Fax    
Email  rajaram.shalini@gmail.com  
 
Source of Monetary or Material Support  
Molbio Diagnostics Private limited, Plot no. 46, Phase II D, Verna Industrial Estate, Verna, Goa-403722 
 
Primary Sponsor  
Name  Molbio Diagnostics Private limited  
Address  Ganesh , Ganpati Temple Road, Verna Industrial estate, Verna, Goa-403722 
Type of Sponsor  Other [Medical equipment manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Riddhi Jadhav  AIIMS Rishikesh  Level 2, Block C, Out Patient Dept of Department of Obstetrics & Gynaecology, AIIMS Rishikesh, Shivaji Nagar, Virbhadra Road, Rishikesh, Dehradun, uttarakhad-249203
Dehradun
UTTARANCHAL 		 9518911425

riddhijadhav38@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Screening for cervical cancer using HPV test and treatment  HIV positive women will be screened for HPV DNA using PCR based test (validated by Cobas test) and HPV positive cases will undergo colposcopy and will be treated according to disease severity 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  All women > 25 years of age attending ART clinic of AIIMS Rishikesh with HIV seropositive status
 
 
ExclusionCriteria 
Details  1. Pregnant women
2. Women who have undergone conization or hysterectomy
3. Not willing to participate in study
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To quantify the number of women with high-risk HPV positivity in HIV seropositive women

To study the distribution of various high risk HPV genotypes in HIV positive women 		 Once (at recruitment) 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of HIV seropositivity (in months since diagnosis) in high-risk HPV positive women.

Duration of ART in weeks in the above group.

CD4 cell count (cells/mm3) at recruitment.

Number of women with cytological abnormalities ≥ ASCUS.

Number of cases with CIN and invasive cervical cancer
 		 Once (at recruitment) 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
As per the GLOBOCAN 2020 data, Cervical cancer is the 3rd most common cancer worldwide . In India, it ranks as the second most common cancer. Cervical cancer differs from any other genital cancer in the sense that it has well defined clinical stages and is caused by persistent infection with carcinogenic types of Human Papillomavirus (HPV) and is a necessary cause for most cervical cancers. The HR-HPV types 16 and 18 are the most common strains, accounting for 70-80% of the total subtypes , while other high risk types accounting for a total of 14 strains are 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 & 68.
Focusing on the Indian territory, the other most prevalent infection is HIV(Human Immunodeficiency Virus) and India ranks 3rd in the world with an absolute number of 2.1 million HIV seropositive people and high-risk types of HPV is an alarming health problem in HIV positive women as immune suppression is the main predisposing factor to HPV infections. It has been observed that Cervical intraepithelial neoplasia (CIN) is more common in HIV-infected females with low CD4 count or AIDS. In order to decrease the overall prevalence of cervical cancer, the most effective strategy is early diagnosis by screening and treatment. Therefore, WHO suggests using HPV DNA detection in a screen, triage and treat approach starting at the age of 25 years with regular screening every 3 to 5 years in HIV seropositive women
Few studies have been published from the Indian subcontinent regarding the prevalence of high-risk HPV and its genotypes in HIV positive women. Therefore, the present study is planned to evaluate HIV seropositive women for high-risk HPV prevalence including its genotypes and detect preinvasive an invasive cervical cancer in this population. The primary objectives of this study is to determine the proportion of HIV positive women with high-risk HPV positivity and the distribution of high-risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 & 68  among HIV positive women. The samples will be collected over a period of 12 months in Gynaecology OPD of AIIMS Rishikesh and females >/= 25 years attending the ART clinic in AIIMS Rishikesh with HIV seropositivity status will undergo HPV sampling, PAPS and VIA. The reports of the Cobas test will be informed to the patient within 14 days of testing. If the test is positive for high-risk HPV or cytology is >ASCUS,  colposcopy will be performed. Cervical biopsy will be taken for high grade lesions (Swede score >5). Cases with low grade lesions (Swede score < 5) will be managed by thermal ablation of the lesion and the transformation zone or managed conservatively with follow up. The primary outcome of this study is to quantify the number of women with high-risk HPV positivity in HIV seropositive women and estimate number of women with various high risk HPV genotypes  . Secondary outcome measures are duration of HIV seropositivity(in months since diagnosis) in high-risk HPV positive women, duration of ART in weeks in the above group, CD4 cell count at recruitment, number of women with cytological abnormalities >/= ASCUS and number of cases with CIN and invasive cervical cancer.
 
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